FDA approves first new sunscreen filter in 20 years

The FDA approved bemotrizinol, a new sunscreen active ingredient, on June 9, 2026, the first new over-the-counter sunscreen filter cleared in the United States in 20 years, according to the agency. The ingredient is authorized at concentrations up to 6%, protects against both UVA and UVB rays, and is approved for use by adults and children as young as 6 months.

What the FDA approved

The FDA reviewed bemotrizinol under a streamlined process created by the CARES Act, the first ingredient to clear U.S. sunscreen approval that way. Manufacturer DSM Nutritional Products LLC submitted the request; the FDA issued a proposed order on December 12, 2025, took public comment through January 26, 2026, and finalized the approval about seven months later. The agency determined bemotrizinol is generally recognized as safe and effective, its official standard for over-the-counter drug ingredients.

"Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence,” HHS Secretary Robert F. Kennedy Jr. said in the FDA’s announcement. FDA Acting Center for Drug Evaluation and Research Director Mike Davis, M.D., called it "exactly the kind of progress we can achieve when we modernize our processes and apply sound science."

Why the ingredient stood out in testing

Bemotrizinol is a chemical, or organic, UV filter, the category that also includes long-used U.S. ingredients like oxybenzone and avobenzone. Chemical filters work by absorbing UV energy at the skin's surface rather than reflecting it, the mechanism mineral filters like zinc oxide and titanium dioxide use instead. What sets bemotrizinol apart, dermatologist Heather Rogers, M.D., told NPR, is that it blocks UVA and UVB rays independently and holds its structure longer in sunlight without breaking down. "So if you go a little longer than two hours to reapply your sunscreen, there will be more protection left," Rogers said. Manufacturer DSM-Firmenich spent roughly $18 million over two decades pursuing the U.S. approval, according to NPR, and the ingredient now carries more safety documentation than any other chemical filter approved for U.S. sunscreens.

What it means for your routine

Because the U.S. regulates sunscreen as an over-the-counter drug rather than a cosmetic, new filters go through years of safety testing before they reach a formula, which is why the domestic filter list has held steady since 2006 even as other countries approved newer options. Bemotrizinol has been sold in European and Asian sunscreens for years under different rules. Like other chemical filters, it applies as a clear formula rather than the visible cast that can come with mineral sunscreens, though people with sensitive or reactive skin may still prefer to patch-test any new sunscreen before adding it to a routine. Sunscreens containing bemotrizinol are expected to reach U.S. shelves around September 2026 under the brand name Parsol Shield, per NPR's reporting, so it will likely show up as one ingredient within larger SPF formulas rather than as a stand-alone product.

Common questions

For a related skincare perspective, read How to patch test a new skincare product.